The purpose of this study is to assess the safety and effectiveness of the SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System for the treatment of subjects with atherosclerotic lesion(s) ≤ 34 mm in length (by visual estimate) in native coronary arteries ≥2.25 mm to ≤4.0 mm in diameter (by visual estimate).

EVOLVE II: A Prospective Multicenter Trial to Assess the Safety and Effectiveness of the SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (SYNERGY Stent System) for the Treatment of Atherosclerotic Lesion(s)

PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).

Device: PROMUS Element Plus

A drug eluting coronary stent system

Experimental: SYNERGY

SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).

Device: SYNERGY

A drug eluting coronary stent system

Detailed Description:

A concurrent, non-randomized, single-arm, pharmacokinetic (PK) substudy and a consecutive, non-randomized, single-arm, Diabetes substudy will also enroll under the EVOLVE II protocol.

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Subject must be at least 18 years of age

Subject (or legal guardian) understands the trial requirements and the treatment procedures and provides written informed consent before any trial-specific tests or procedures are performed

For subjects less than 20 years of age enrolled at a Japanese site, the subject and the subject's legal representative must provide written informed consent before any study-specific tests or procedures are performed

Subject is participating in another investigational drug or device clinical trial that has not reached its primary endpoint

Subject intends to participate in another investigational drug or device clinical trial within 12 months after the index procedure

Subject with known intention to procreate within 12 months after the index procedure (women of child-bearing potential who are sexually active must agree to use a reliable method of contraception from the time of screening through 12 months after the index procedure)

Subject is a woman who is pregnant or nursing (a pregnancy test must be performed within 7 days prior to the index procedure in women of child-bearing potential)

Angiographic Exclusion Criteria (visual estimate):

Planned treatment of more than 3 lesions

Planned treatment of lesions in more than 2 major epicardial vessels

Planned treatment of a single lesion with more than 1 stent

Subject has 2 target lesions in the same vessel that are separated by less than 15 mm (by visual estimate)

Target lesion(s) is located in the left main

Target lesion(s) is located within 3 mm of the origin of the left anterior descending (LAD) coronary artery or left circumflex (LCx) coronary artery by visual estimate

Target lesion(s) is located within a saphenous vein graft or an arterial graft

Target lesion(s) will be accessed via a saphenous vein graft or arterial graft

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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01665053